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Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas

A Phase III Multicenter Open-label Randomized Trial to Evaluate Efficacy and Safety of Folfirinox (FFX) Versus Combination of CPI-613 With Modified Folfirinox (mFFX) in Patients With Metastatic Adenocarcinoma of the Pancreas

NCT03504423•Cornerstone Pharmaceuticals

View on ClinicalTrials.gov

Summary

A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed metastatic Stage IV adenocarcinoma of the pancreas
•2. No prior treatments for stage IV pancreatic adenocarcinoma (prior adjuvant or neoadjuvant treatment is allowed provided completed \> 6 months prior to disease recurrence)
•3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
•4. Male and female patients 18 - 75 years of age
•5. Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
•6. Expected survival \>3 months
•7. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted highly effective contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive(s), intrauterine hormone releasing system (IUS), bilateral tubal occlusion or vasectomized partner) during and for 6 months after last study dose and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation, at monthly interval (day 1 of every even numbered cycle), at the end of systemic exposure, and at 30 days after the systemic exposure
•8. Males with female partners (of childbearing potential) and female partners (of child bearing potential) with male partners must agree to use double barrier contraceptive measure (a combination of male condom with either cap, diaphragm or sponge with spermicide) in addition to oral contraception or avoidance of intercourse during the study and for 6 months after last study dose is received
•9. At least 2 weeks must have elapsed from any prior surgery with resolution of any sequela for randomization
•10. Laboratory values ≤2 weeks prior to randomization must be:
+42 more criteria

Exclusion Criteria

•1. Endocrine or acinar pancreatic carcinoma
•2. Known cerebral metastases, central nervous system (CNS), or epidural tumor
•3. Prior treatment with any chemotherapy for metastatic adenocarcinoma of the pancreas
•4. Completion of a gemcitabine-based adjuvant chemotherapy regimen within less than 6 months at the time of screening.
•5. Receipt of neoadjuvant or adjuvant FOLFIRINOX therapy if \<6 months prior to disease recurrence
•6. Patients with hypersensitivity to devimistat, FFX treatment or any of their excipients
•7. Presence of clinically significant abdominal ascites
•8. Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of devimistat treatment
•9. Serious medical illness that would potentially increase patients' risk for toxicity
•10. Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
+13 more criteria

Locations (74)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

City of Hope

Duarte, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, California, United States

Pacific Hematology Oncology Associates

San Francisco, California, United States

Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Mayo Clinic Hospital

Jacksonville, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Key Dates

Start Date

November 9, 2018

Primary Completion Date

August 16, 2021

Completion Date

January 2, 2022

Last Updated

January 3, 2023

Enrollment

528

ACTUAL participants

Conditions

Pancreatic Cancer Metastatic

Interventions

CPI 613, mFolfirinox

DRUG

Folfirinox

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas

Inclusion Criteria

Exclusion Criteria

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